Exercise and Pharmacotherapy for Anxiety in Cardiac Patients

心脏病患者焦虑的运动和药物治疗

基本信息

批准号：
9113594
负责人：
James A Blumenthal
金额：
$ 78.02万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-01 至 2020-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9113594
关键词：
Accounting Acute Coronary Event Adult Adverse effects Adverse event Affect American American Heart Association Anti-Anxiety Agents Anxiety Anxiety Disorders Autonomic nervous system Biological Markers Blood Blood Vessels Cardiac Cardiac rehabilitation Cardiovascular system Cause of Death Characteristics Cholesterol Chronic Clinic Clinical Clinical Research Clinical Trials Design Clinical assessments Coronary heart disease Data Diagnosis Effectiveness Escitalopram Event Exercise Health Health Care Costs Heart Hospitalization Hypertension Inflammation Intervention Lexapro Literature Maintenance Major Depressive Disorder Measures Mediating Medical Mental Depression Monitor Morbidity - disease rate Myocardial Odds Ratio Outcome Outpatients Participant Patients Pharmaceutical Preparations Pharmacotherapy Physiological Placebos Population Prevalence Prognostic Factor Psychosocial Factor Quality of life Randomized Randomized Clinical Trials Recommendation Regulation Reporting Research Risk Risk Factors Selective Serotonin Reuptake Inhibitor Severity of illness Smoking Therapeutic Time Training United States Woman Work anxiety symptoms anxiety treatment anxious base cardiovascular risk factor clinically significant cost depressive symptoms design exercise training follow-up heart disease risk improved improved outcome men mortality outcome forecast prognostic significance psychologic reduce symptoms vascular endothelial dysfunction

项目摘要

DESCRIPTION (provided by applicant): Coronary heart disease (CHD) is the leading cause of death in the United States, affecting 600,000 Americans each year. The term "cardiovascular vulnerable patient" has been used to describe patients susceptible to acute coronary events based upon plaque, blood, or myocardial characteristics. Recent evidence has suggested that anxiety, which is common in CHD patients, may be a significant and independent prognostic factor that also increases cardiovascular vulnerability. This evidence has provided a rationale for reducing anxiety in cardiac patients. Anxiolytic medications, especially selective serotonin reuptake inhibitors (SSRIs), may be effective in this regard, although the value of these medications in reducing anxiety has not been widely studied in cardiac patients and their value in improving clinical outcomes is not known. Exercise also may be effective in reducing anxiety, although the therapeutic potential of exercise has remained unfulfilled due to a paucity of data from well-designed clinical studies. The study proposed in this application will (a) evaluate the effectiveness of exercise training and anxiolytic medication in reducing anxiety in vulnerable cardiac patients; (b) examine changes in intermediate endpoints, including measures of autonomic nervous system dysregulation, vascular endothelial dysfunction, and chronic inflammation, which also serve as physiologic markers of vulnerability to adverse cardiac events; (c) follow participants for up to 4 years to assess clinical events including fatal and non fatal cardiac events, hospitalizations, and medical costs; and (d) explore possible mechanisms by which the interventions improve outcomes. One hundred fifty men and women with CHD and an anxiety disorder or elevated symptoms of anxiety will be randomly assigned to Exercise, Medication (escitalopram), or Placebo. Before and after 3 months of treatment, patients will undergo clinical assessments of anxiety and measures of autonomic nervous system regulation, vascular endothelial function, and inflammation. A six month follow-up will assess maintenance of psychological benefit and clinical outcomes will be monitored for up to 4 years. The data generated from this study will have important clinical significance by determining the extent to which exercise and medication may reduce anxiety, improve intermediate markers of CHD risk, and improve medical outcomes including clinical events and CHD-related hospitalizations.

描述（由申请人提供）：冠心病 (CHD) 是美国的首要死因，每年影响 600,000 名美国人。“心血管脆弱患者”一词用于描述易患急性冠脉事件的患者。最近的证据表明，冠心病患者中常见的焦虑可能是一个重要且独立的预后因素，也增加了心血管脆弱性。抗焦虑药物，尤其是选择性血清素再摄取抑制剂（SSRIs），在这方面可能有效，尽管这些药物在减轻焦虑方面的价值尚未在心脏病患者中得到广泛研究，而且它们在改善临床结果方面的价值尚不清楚。目前尚不清楚，尽管由于缺乏精心设计的临床研究数据，运动的治疗潜力仍未得到发挥，但本申请中提出的研究将（a）评估运动的有效性。减少心脏病患者焦虑的培训和抗焦虑药物；(b) 检查中间终点的变化，包括自主神经系统失调、血管内皮功能障碍和慢性炎症的测量，这些也是易受不良心脏事件影响的脆弱生理标志； (c) 跟踪参与者长达 4 年以评估临床事件，包括致命和非致命的心脏事件、住院治疗和医疗费用；以及 (d) 探索干预措施改善结果的可能机制。将将 150 名患有先心病和焦虑症或焦虑症状加重的男性和女性随机分配到运动、药物治疗组。艾司西酞普兰）或安慰剂。在治疗 3 个月之前和之后，患者将接受焦虑的临床评估以及自主神经系统调节、血管内皮功能和炎症的测量，六个月的随访将评估心理益处和临床效果的维持。结果将这项研究产生的数据将进行长达 4 年的监测，通过确定运动和药物可以在多大程度上减轻焦虑、改善冠心病风险的中间标志以及改善包括临床事件和冠心病相关的医疗结果。住院治疗。